golimumab (mk-8259 / sch900259) treatment withdrawal in participants with non-radiographic axial spondyloarthritis (go-back) (mk-8259-038)

Conditions: Spondyloarthritis

Summary: the purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (glm) administered by subcutaneous (sc) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. the primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.


Eligibility criteria:
inclusion criteria: * is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication * has chronic back pain of ≥3 months duration by history * has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axspa) with disease duration \<= 5 years * meets one of the following criteria: 1. has active inflammation on magnetic resonance imaging (mri) highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (spa) characteristics: * inflammatory back pain * arthritis (physician-diagnosed) * enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the achilles tendon or plantar fascia) * dactylitis (physician-diagnosed) * psoriasis (physician-diagnosed) * history of physician-diagnosed inflammatory bowel disease (ibd) * history of uveitis confirmed by an ophthalmologist * good response to nonsteroidal anti-inflammatory drugs (nsaid) * family history of spa (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or ibd) * elevated c-reactive protein (crp) * human leukocyte antigen b27 (hla-b27)+ gene or 2. has a hla-b27+ gene and 2 or more of the following spa characteristics: * inflammatory back pain * arthritis (physician-diagnosed) * enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the achilles tendon or plantar fascia) * dactylitis (physician-diagnosed) * psoriasis (physician-diagnosed) * history of physician-diagnosed inflammatory bowel disease (ibd) * history of uveitis confirmed by an ophthalmologist * good response to nonsteroidal anti-inflammatory drugs (nsaid) * family history of spa (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or ibd) * elevated c-reactive protein (crp) * has elevated crp at screening or evidence of active inflammation in the sacroiliac joints on mri * has an ankylosing spondylitis disease activity score (asdas) \>= 2.1 at screening * shows high disease activity at screening and baseline of both a total back pain score of ≥4 and a bath ankylosing spondylitis disease activity index (basdai) score of \>= 4 * has an acceptable history of nsaid use * has no history of untreated latent or active tuberculosis (tb) prior to screening * has had no recent close contact with a person with active tb or, if there has been such contact, will undergo additional evaluations and receive appropriate treatment for latent tb * agrees to undergo screening for hepatitis b virus (hbv) and demonstrates negative results for hepatitis b surface antigen (hbsag) and hbv deoxyribonucleic acid (dna) exclusion criteria: * has bilateral sacroiliitis grade 2 or unilateral sacroiliitis grade 3 or grade 4 on conventional x-rays * is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication * intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication * has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial * has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents * has received any treatment listed below more recently than the indicated off-drug period prior to screening * • disease-modifying anti-rheumatic drugs (30 days off drug) * • live vaccinations (3 months off drug) * • investigational medications (30 days or 5 half-lives off drug, whichever is longer) * • bacille calmette-guerin (bcg) vaccination (12 months off drug) * has any systemic inflammatory condition, including psoriatic arthritis, active lyme disease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirus infection, rheumatoid arthritis, active uveitis, or active ibd * has a history of latent or active granulomatous infection prior to screening * had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to screening * has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced * had a serious infection, has been hospitalized for an infection, or has been treated with iv antibiotics for an infection within 2 months prior to baseline * had a history of, or ongoing, chronic or recurrent infectious disease * is known to be infected with human immunodeficiency virus (hiv) or seropositive for hepatitis c virus (hcv) * has had a chest x-ray within 2 months prior to screening that shows an abnormality suggestive of a current active infection or malignancy * has a history of lymphoproliferative disease * has had a malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of cervix that has been surgically cured) * has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis * has a history of or concurrent congestive heart failure of any grade * has a transplanted organ (with the exception of a corneal transplant performed \>= 3 months prior to baseline) * has current signs or symptoms of significant medical illness which could interfere with the trial, or require treatment that might interfere with the trial * is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years